Guidance Documents

Question and answer concerning the bulk destruction of controlled substances during the civil unrest.

The Guide addresses, among other things, who and what is covered by the FCPA's anti-bribery and accounting provisions; the definition of a "foreign official"; what constitute proper and improper gifts, travel and entertainment expenses; the nature of facilitating payments; how successor liability applies in the mergers and acquisitions context; and the hallmarks of an effective corporate compliance program.

Question and answer concerning controlled substance prescription transfers during civil unrest.

Question and answer concerning off-site dosing of narcotic treatment program patients during civil unrest.

Question and answer concerning moving controlled substances to another address without changing the address of the DEA registered location.

Question and answer concerning reporting of theft and/or loss of controlled substances during civil unrest and looting.

The guidance discusses the meaning of the term “agent of a foreign principal” as used in FARA.

During the Covid19 Public Health Emergency, DEA will temporarily permit registered practitioners such as hospitals, pharmacies, and physicians to distribute controlled substances (CS) in excess of five percent of their total number of dosage units of CS distributed to other registered dispensers during this calendar year, without registering as a distributor.  All DEA security, recordkeeping and other applicable regulations, including state requirements, remain in effect.

Due to the Covid-19 Public Health Emergency, DEA-registered hospital/clinics may utilize alternate satellite hospital/clinic locations providing temporary services under their current registrations. DEA will allow such satellite hospitals/clinics to handle controlled substances and to receive shipments of controlled substances directly from distributors.  DEA must be notified by all registered hospital/clinics of any satellite locations intending to handle controlled substances.

Due to the Covid-19 Public Health Emergency, DEA has issued guidance to Distributors to ensure regulatory compliance regarding secure delivery of controlled substance shipments to hospitals, pharmacies and NTPs, documentation and recordkeeping, due diligence requirements, and authorization for emergency alternate distribution sites.

During the COVID-19 public health emergency, DEA-registered hospitals/clinics may conduct remote identity proofing of individual practitioners to issue authentication credentials to eligible practitioners engaged in electronic prescribing of controlled substances, in conformance with existing regulations. DEA suggests using a device that allows for real-time, two-way, audio-visual interactive communication to do so.

In response to the COVID19 public health emergency(PHE) declared by HHS, the DEA has adopted policies to allow DEA reg. practitioners to prescribe controlled substances(CS) without having to interact in-person with their patients. This chart only addresses prescribing CS and doesn’t address administering or direct dispensing of CS, including by OTPs or hospitals. These go into effect 3-31-20, and will remain in effect for the duration of the PHE, unless DEA specifies an earlier date.